Medicament Delivery Device

ABSTRACT

A medicament delivery device comprises a needle configured to move between a retracted position and an inserted position; an insertion mechanism to move the needle from the retracted position to the inserted position when activated; a locking arm which, in a locked position, is engaged with the insertion mechanism to prevent activation of the insertion mechanism and, in an unlocked position, is disengaged from the insertion mechanism; a retraction mechanism to move the needle from the inserted position to the retracted position when activated; and a trigger configured to move between a disengaged position and an engaged position. On moving from the disengaged position to the engaged position, the trigger is configured to move the locking arm from the locked position to the unlocked position. On moving from the engaged position to the disengaged position, the trigger is configured to activate the retraction mechanism.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation application of U.S.application Ser. No. 16/321,734, filed on Jan. 29, 2019, which is thenational stage entry of International Patent Application No.PCT/EP2017/069135, filed on Jul. 28, 2017, and claims priority toApplication No. EP 16182306.7, filed on Aug. 2, 2016, the disclosures ofwhich are incorporated herein by reference.

TECHNICAL FIELD

The present invention relates to a device for delivery of medicament toa patient.

BACKGROUND

A variety of diseases exist that require regular treatment by injectionof a medicament and such injections can be performed by using injectiondevices. Injection or infusion pumps of the type known as patch pumpsfor delivering injections of medicament are known in the art. Anothertype of injection pump that is gaining traction is the bolus injectordevice. Some bolus injector devices are intended to be used withrelatively large volumes of medicament, typically at least 1 ml andmaybe a few ml. Injection of such large volumes of medicament can takesome minutes or even hours. Such high capacity bolus injector devicescan be called large volume devices (LVDs). Generally, such devices areoperated by the patients themselves, although they may also be operatedby medical personnel.

To use a patch pump or bolus injector device, such as an LVD, it isfirst supported on a suitable injection site on a patient's skin. Onceinstalled, injection is initiated by the patient or another person(user). Typically, the initiation is effected by the user operating anelectrical switch, which causes a controller to operate the device.Operation includes firstly injecting a needle into the user and thencausing the injection of medicament into the user's tissue. Biologicalmedicaments are being increasingly developed which comprise higherviscosity injectable liquids and which are to be administered in largervolumes than long-known liquid medicaments. LVDs for administering suchbiological medicaments may comprise a pre-filled disposable drugdelivery device or, alternatively, a disposable drug delivery deviceinto which a patient or medical personnel must insert a drug cartridgeprior to use.

SUMMARY

According to an aspect a medicament delivery device is provided,including a needle configured to move between a retracted position andan inserted position; an insertion mechanism to move the needle from theretracted position to the inserted position when activated; a lockingarm which, in a locked position, is engaged with the insertion mechanismto prevent activation of the insertion mechanism and, in an unlockedposition, is disengaged from the insertion mechanism; a retractionmechanism to move the needle from the inserted position to the retractedposition when activated; and a trigger configured to move between adisengaged position and an engaged position; wherein, on moving from thedisengaged position to the engaged position, the trigger is configuredto move the locking arm from the locked position to the unlockedposition; and wherein, on moving from the engaged position to thedisengaged position, the trigger is configured to activate theretraction mechanism.

The locking arm may be slidably mounted and pivotably coupled to anunlocking lever such that a rotation of the unlocking lever causes asliding movement of the locking arm.

The trigger, on moving from the disengaged position to the engagedposition, may engage with the unlocking lever to rotate the unlockinglever, such that the locking arm is moved from the locked position tothe unlocked position.

The unlocking lever may be pivotably mounted at a midpoint, and mayinclude a first end pivotably coupled to the locking arm and a secondend arranged to engage with the trigger.

The unlocking lever may be formed having an angle at the pivot point,and may be arranged such that movement of the trigger along a firstdirection causes a rotation of the first end, and a resulting rotationof the second end causes a sliding movement of the locking arm along asecond direction different to the first direction.

The insertion mechanism may include a user actuator arranged to bepushed by a user to activate the insertion mechanism.

The locking arm in the locked position may be engaged with the useractuator to prevent movement of the user actuator.

The locking arm may extend along the direction of sliding motion.

In the locking position, an end of the locking arm may be disposedwithin a receiving notch formed in the user actuator to prevent movementof the user actuator in a direction perpendicular to the locking arm.

In the unlocked position, the locking arm may be withdrawn from thenotch.

The insertion mechanism may include biasing means to urge the needletowards the inserted position; and a blocking element arranged, in ablocking position, to prevent the needle from moving from the retractedposition to the inserted position and arranged, in a release position,to allow the needle to move from the retracted position to the insertedposition.

The user actuator may be arranged to urge the blocking element from theblocking position to the release position when pushed.

The insertion mechanism may include an injection arm pivotably mountedat one end and pivotably coupled to the needle at the other end; and aguide member configured to restrict movement of the needle to a linearmovement between the retracted position and the inserted position inresponse to a pivoting action of the injection arm.

The blocking element in the blocking position may be arranged inabutment with the injection arm to prevent movement of the needle to theinserted position.

The blocking element may be pivotably mounted to rotate between theblocking position and the release position.

The blocking element may be formed having a substantially triangularshape which is pivotably mounted at a first corner.

A second corner of the blocking element may be in abutment with theinjection arm when the blocking element is in the blocking position, andthe user actuator may be configured to apply a force at a third cornerof the blocking element when pushed.

The biasing means may include a torsion spring.

The torsion spring may be a coil spring fixed around the pivot of theinjection arm.

A first end of the coil may be fixed in position, and a second end ofthe coil may extend along the injection arm to push the injection armtowards the inserted position.

The retraction mechanism may include a return actuator pivotably mountedto rotate between a first position and a second position.

The return actuator in the first position may be arranged to abut withthe injection arm in the inserted position, and the return actuator maybe configured to urge the injection arm and needle to the retractedposition of the needle when moved to the second position.

The return actuator may be mounted to rotate around the pivot point ofthe injection arm.

The retraction mechanism may include biasing means configured to urgethe return actuator towards the second position.

The trigger in the engaged state may be configured to engage with thereturn actuator to retain the return actuator in the first position, andthe trigger in the disengaged state may be disengaged from the returnactuator.

The biasing means may include a torsion spring.

The torsion spring may be a coil spring, having a first end of the coilfixed in position and a second end of the coil in abutment with thereturn actuator to push the return actuator towards the second position.

The coil of the torsion spring may not be fixed in position between thefirst end and second end.

The blocking element, in the blocking position, may be engaged with thereturn actuator to retain the return actuator in the first position and,in the release position, may be disengaged from the return actuator.

The trigger may be formed having a retaining slot.

In the first position, the return actuator may be aligned with theretaining slot, disposed within the retaining slot and prevented frommoving to the second position when the trigger is in the engagedposition, and may be released by the retaining slot when the triggermoves from the engaged position to the disengaged position.

The return actuator, in the second position, may be not aligned with theretaining slot and may abut with the trigger to prevent the trigger frommoving from the disengaged position to the engaged position.

The trigger may be pivotably mounted to rotate between the engagedposition and the disengaged position and the trigger may be biasedtowards the disengaged position.

The first end of the spring of the retraction mechanism may be fixed tothe trigger to push the trigger towards the disengaged position.

The device may include an outer housing.

In the retracted position, the needle may be disposed within the housingand, in the inserted position, the needle may extend out of the housing.

The needle in the inserted position may extend through a contact surfaceof the housing, and the trigger in the disengaged position may extendthrough the contact surface.

The trigger in the disengaged position may extend beyond the needle inthe inserted position.

The trigger in the engaged position may be disposed within the housing,and the trigger may be configured to be moved to the engaged positionwhen the contact surface is placed against a user.

The trigger may be pivotably mounted to a point within the housing, suchthat the trigger extends parallel to the contact surface in the engagedposition, and extends at an angle from the contact surface in thedisengaged position.

A vertical extent of the housing, measured perpendicular to the contactsurface, may be smaller than a horizontal extent of the housing.

The device may include a medicament reservoir and a medicament which isretained in the medicament reservoir.

These and other aspects of the invention will be apparent from andelucidated with reference to the embodiments described hereinafter.

BRIEF DESCRIPTION OF THE FIGURES

Exemplary embodiments of the present invention are described withreference to the accompanying drawings, in which:

FIG. 1 is a schematic side view of an injection device according to anembodiment;

FIG. 2 is an exploded view of the FIG. 1 injection device;

FIG. 3A is a schematic side view of the FIG. 1 injection device;

FIG. 3B is a schematic side view of the FIG. 1 injection device;

FIG. 4A is a schematic side view of the FIG. 1 injection device;

FIG. 4B is a schematic side view of the FIG. 1 injection device;

FIG. 5A is a schematic side view of the FIG. 1 injection device;

FIG. 5B is a schematic side view of the FIG. 1 injection device;

FIG. 5C is a schematic side view of the FIG. 1 injection device;

FIG. 6A is a schematic side view of the FIG. 1 injection device;

FIG. 6B is a schematic side view of the FIG. 1 injection device;

FIG. 6C is a schematic side view of the FIG. 1 injection device;

FIG. 7A is a schematic side view of the FIG. 1 injection device;

FIG. 7B is a schematic side view of the FIG. 1 injection device;

FIG. 8 is a schematic side view of the FIG. 1 injection device;

FIG. 9 is a schematic side view of the FIG. 1 injection device;

FIG. 10 is a schematic side view of the FIG. 1 injection device;

FIG. 11 is a schematic side view of the FIG. 1 injection device; and

FIG. 12 is a schematic side view of the FIG. 1 injection device.

DETAILED DESCRIPTION

A medicament delivery device, as described herein, may be configured toinject a medicament into a patient. For example, delivery could besub-cutaneous, intra-muscular, or intravenous. Such a device could beoperated by a patient or by a care-giver, such as a nurse or physician.The device can include a cartridge-based system that requires piercing asealed ampule before use. The device can include a large volume device(“LVD”) or patch pump, configured to adhere to a patient's skin for aperiod of time (e.g., about 5, 15, 30, 60, or 120 minutes) to deliver a“large” volume of medicament (typically about 2 ml to about 10 ml).

In combination with a specific medicament, the presently describeddevices may also be customized in order to operate within requiredspecifications. For example, the device may be customized to inject amedicament within a certain time period (e.g. about 10 minutes to about60 minutes for an LVD). Other specifications can include a low orminimal level of discomfort, or to certain conditions related to humanfactors, shelf-life, expiry, biocompatibility, environmentalconsiderations, etc. Such variations can arise due to various factors,such as, for example, a drug ranging in viscosity from about 3 cP toabout 50 cP. Consequently, a drug delivery device will often include ahollow needle ranging from about 25 to about 31 Gauge in size. Commonsizes are 27 and 29 Gauge.

The medicament delivery devices described herein can also include one ormore automated functions. For example, one or more of needle insertion,medicament injection, and needle retraction can be automated. Energy forone or more automation steps can be provided by one or more energysources. Energy sources can include, for example, mechanical, pneumatic,chemical, or electrical energy. For example, mechanical energy sourcescan include springs, levers, elastomers, or other mechanical mechanismsto store or release energy. One or more energy sources can be combinedinto a single device. Devices can further include gears, valves, orother mechanisms to convert energy into movement of one or morecomponents of a device.

The one or more automated functions of a device may each be activatedvia an activation mechanism. Such an activation mechanism can includeone or more of a button, a lever, a needle sleeve, or other activationcomponent. Activation of an automated function may be a one-step ormulti-step process. That is, a user may need to activate one or moreactivation components in order to cause the automated function. Forexample, in a one-step process, a user may depress a trigger againsttheir body in order to cause injection of a medicament. Other devicesmay require a multi-step activation of an automated function. Forexample, a user may be required to depress a button and deploy a needlein order to cause injection.

In addition, activation of one automated function may activate one ormore subsequent automated functions, thereby forming an activationsequence. For example, activation of a first automated function mayactivate at least two of needle insertion, medicament injection, andneedle retraction. Some devices may also require a specific sequence ofsteps to cause the one or more automated functions to occur. Otherdevices may operate with a sequence of independent steps.

Some medicament delivery devices can also include one or more functionsof a safety syringe, pen-injector, or auto-injector. For example, adelivery device could include a mechanical energy source configured toautomatically inject a medicament (as typically found in anauto-injector) and a dose setting mechanism (as typically found in apen-injector).

FIGS. 1 and 2 show a medicament delivery device 10, which in theexemplary embodiment comprises a bolus injector device (hereafter simplyreferred to as “device 10”), according to a first embodiment. The device10 comprises a housing 11 containing a medicament delivery mechanism.The device 10 can include an LVD.

FIG. 1 is a schematic cross-section view showing the device 10. FIG. 2is an exploded view showing components of the medicament deliverysystem. The medicament delivery mechanism is only shown schematicallyand a number of the functional components are omitted for the sake ofclarity and brevity, but the device 10 includes a needle 12 forinjection of the liquid medicament into a patient's body. The liquidmedicament may be provided in a reservoir (not shown) within themedicament delivery mechanism, or may be provided externally of thedevice 10.

Although not shown in the figures, a medicament delivery mechanism of adevice may include one or more of the following components. A controllerconfigured to control operation of the device 10. A medicament reservoircontaining a supply of medicament to be administered to a patient. Themedicament reservoir may, for example, include a cartridge or a vialformed of glass. A plunger maybe provided within the cartridge andplunger driver mechanically coupled to the plunger. The plunger drivermay be controllable to move the plunger along the medicament cartridge.The force provided by the plunger causes medicament to be expelledthrough a medicament delivery aperture in the medicament cartridge andalong a medicament delivery tube to the needle 12 to be expelled throughthe bore of the needle 12. An electrical power source in the form of abattery to power to the controller. The battery may also provideelectrical power the plunger driver, if this is an electrically drivendevice.

The housing 11 is shown schematically as a rectangular case in FIG. 1 .The housing 11 may be a box having a rectangular cross section.Alternatively, the housing 11 may be cylindrical, with the cross sectionshown through the widest point. Further alternatively, the housing 11may be approximately dome shaped or may have any other suitable shapeand profile to contain the components of the medicament deliverymechanism.

The housing 11 includes a support 16, as shown in FIG. 2 . The support16 is fixed in position with the housing 11. The support 16 fixes thepositions and movements of the components of the medicament deliverymechanism, as will be described below.

The device 10 generally comprises a housing upper side 11 a and a lowerside 11 b. The lower side 11 b is flat. The upper side 11 a may be flatand parallel to the lower side 11 b. Alternatively, the upper side 11 amay be curved or shaped e.g. to be easily held. In an alternativeembodiment to lower side 11 b may be curved. The lower side 11 b may beshaped to fit against the patient's skin when the device 10 is inposition.

In use, the lower side 11 b of the housing 11 is intended to be acontact surface that is placed against a patient's skin during amedicament administration process. The lower side 11 b forms a flatcontact surface. The lower side 11 b may comprise an adhesive layer toremovably adhere to a patient's skin. The lower side 11 b may include acushioning layer, for example, a foam or gel layer. A height of thedevice 10, measured between the upper side 11 a and the lower side 11 b,may be short with respect to the size of the lower side 11 b. A lengthof the lower side 11 b may be greater than the height of the device 10.A width of the lower side 11 b may be greater than the height of thedevice 10. The device 10 is stable when placed in position against apatient's skin.

The contact surface or lower side 11 b of the housing 11 includes anaperture 13 through which the needle 12 can project in use. The needle12 is arranged to extend in a direction perpendicular to the lower side11 b. A length of needle 12 defines a first axis of the device 10. Thefirst axis is perpendicular to the contact surface with a patient's skinwhen the lower side 11 b is placed against the patient's skin. Theheight of the device 10 is measured along the first axis.

A second axis of the device 10 is perpendicular to the first axis. Thesecond axis is parallel to the lower side 11 b of the housing 11. FIG. 2shows an exploded view of the device 10, with components of themedicament delivery system separated along the second axis. In FIG. 1 ,the second axis extends perpendicular to the plane of the cross section.A third axis of the device 10 is perpendicular to the first axis and thesecond axis. In FIG. 1 , the third axis extends horizontally from leftto right.

The needle 12 of the device 10 is movable along the first axis. Theneedle 12 is prevented from moving except to move along its length. Theneedle 12 can be moved between a retracted position and an insertedposition. In the retracted position the needle 12 is disposed within thehousing 11 of the device 10. In the inserted position, the needle 12projects from the lower side 11 b of the housing 11 through the aperture13. The needle 12 is arranged in the inserted position so as to pierceand inject a patient's skin when the device 10 is attached to a patient.

The needle 12 is fixedly attached to a needle support 12 a. The needle12 is attached at an upper end to the needle support 12 a. The needle 12extends downwards from the needle support 12 a. The needle support 12 ais a thin rectangular plate. The needle support 12 a is arranged in aplane perpendicular to the second axis. The needle support 12 a may beany other suitable shape.

The needle 12 and needle support 12 a are arranged to fit within acorresponding groove in the housing support 16. The groove in thehousing support 16 extends vertically along the first axis. The needlesupport 12 a is in abutment with the sides of the groove. The needle 12is prevented from moving sideways along the third axis when the needlesupport 12 a is disposed in the groove.

The needle support 12 a comprises a lateral protrusion. The needlesupport 12 a has a protrusion extending along the second axis. Theprotrusion of the needle support 12 a extends away from the housingsupport 16. The protrusion extends out of the groove of the housingsupport 16. The protruding part of the needle support 12 a is arrangedto engage with a needle guide 12 b.

The needle guide 12 b is a generally rectangular frame. The needle guide12 b is arranged in a plane perpendicular to the second axis. The needleguide 12 b comprises a vertical slot extending along first axis. Theprotruding part of the needle support 12 a extends into the slot of theneedle guide 12 b. The needle support 12 a is in abutment with the sidesof the slot of the needle guide 12 b. The needle guide 12 b prevents theneedle 12 and the needle support 12 a from sideways movement along thethird axis.

The needle guide 12 b is fixed in position against the housing support16. The needle support 12 a and the needle 12 are arranged between thehousing support 16 and the needle guide 12 b. The needle guide 12 bretains the needle support 12 a in the groove of the housing support 16.The needle guide 12 b prevents the needle 12 and needle support 12 afrom movement along the second axis. The needle 12 is therefore free tomove along the first axis only

The medicament delivery mechanism of the device 10 comprises a needleinsertion mechanism 20, a needle retraction mechanism 30 and a triggerarrangement 40. The needle insertion mechanism 20 is configured to movethe needle 12 from the retracted position into the inserted position.The needle retract mechanism 30 is configured to retract the needle 12from the inserted position into the retracted position. The triggerarrangement 40 allows the user to activate the medicament deliveryprocess. The trigger arrangement 40 may activate the needle insertionmechanism 20. Elements of the trigger arrangement 40 may be consideredto be part of the needle insertion mechanism 20.

The device 10 further comprises a contact trigger 14. The contacttrigger 14 is an example of a trigger. The contact trigger 14 isconfigured to control the operation of the insertion mechanism 20 andthe retraction mechanism 30 according to whether or not the device 10 isplaced on the body of a patient. Alternatively, the device may include amanual trigger. For example, the trigger may be a grip trigger, toensure the device is held securely throughout the medicament deliveryprocess.

The contact trigger 14 is configured to lock the insertion mechanism 20until the device 10 is placed on a contact surface. The contact trigger14 can prevent activation of the insertion mechanism 20 when the device10 is not placed on the body. The contact trigger 14 is furtherconfigured to activate the retraction mechanism 30 when the device 10 isremoved from the body. The contact trigger 14 of the device 10 canprevent unintentional activation of the insertion mechanism 20 when thedevice 10 is not in position on the body of a patient. The contacttrigger 14 also avoids unnecessary exposure of the needle 12 when themedicament delivery process has been completed. The contact trigger 14can improve the safety of the medicament delivery operation.

The needle insertion mechanism 20 comprises an injection arm 21 and aninjection spring 22. The injection arm 21 is an elongate member. Theinjection arm 21 is configured to pivot around a point at one end of theinjection arm 21. The injection arm 21 is fixed to the housing support16 at the pivot point. The injection arm 21 comprises a circular hole atthe pivot point, configured to fit over a corresponding axle extendingfrom the housing support 16. The injection arm 21 freely rotates aroundthe axle of the housing support 16. The injection arm 21 is arranged torotate in a plane perpendicular to the second axis.

The needle 12 is coupled to the end of the injection arm 21 distal fromthe pivot. The injection arm 21 comprises an elongate slot extendingalong the injection arm 21. The slot of the injection arm 21 may be openat the distal end of the injection arm 21, as shown in FIG. 1 .Alternatively, the slot of the injection arm 21 may be closed at end, asshown in FIG. 2 .

The injection arm 21 is configured to engage with the needle support 12a. The protruding part of the needle support 12 a passes through theslot of the injection arm 21. The needle guide 12 b is disposed betweenthe injection arm 21 and the needle 12. The injection arm 21 extendsgenerally along the third axis, such that rotation about the pivotcauses the distal end to move up and down along the first axis. As theinjection arm 21 is rotated, the sides of the slot exert a force on theneedle support 12 a. The injection arm 21 exerts a force on the needlesupport 12 a in an upwards or downwards direction along the first axis.

Rotation of the injection arm 21 causes the needle support 12 a to movealong the groove of the housing support 16. Rotation of the injectionarm 21 is translated into movement of the needle 12 along the firstaxis. The injection arm 21 is configured to pivot between a retractedposition and an inserted position, corresponding to the retractedposition and the inserted position of the needle 12. The retractedposition of the injection arm 21 is shown in FIG. 3A and the insertedposition is shown in FIG. 3B.

The injection arm 21 comprises a peg 23. The peg 23 is arranged toengage with the injection spring 22. The peg 23 is also for engagingwith the trigger arrangement 40. The peg 23 is positioned midway alonginjection arm 21. The peg 23 may be positioned at any point between thepivot and the slot of the injection arm 21. The peg 23 extends from theinjection arm 21 along the second axis. The peg 23 extends in adirection away from the housing support 16.

The injection spring 22 is an example of a needle driver to drive theneedle insertion mechanism 20. The injection spring 22 is a torsionspring, for example, a wire coil spring with a straight portionextending from each end of the coil. The ends of the injection spring 22extend with an angle between them. The injection spring 22 is tensionedso as to reduce the angle between the ends of the coil when released.Alternatively, the needle driver may be, for example, a linear coilspring, a hydraulic or pneumatic piston, or an electric motor. A batterymay provide an energy source to power the needle driver. The injectionspring 22 is configured to move the needle 12 from the retractedposition to the inserted position.

The injection spring 22 is arranged to apply a force which moves theinjection arm 21 to the inserted position. The coil of the injectionspring 22 is disposed around the pivot point of the injection arm 21.The coil is disposed around the same axle of the housing support 16 asthe injection arm 21. A first end of the injection spring 22 is fixed inposition. A further peg protruding from the housing support 16 isarranged in abutment with the first end of the injection spring 22. Thehousing support 16 prevents the first end of the injection spring 22from moving towards a second end of the injection spring 22.

The second end of the injection spring 22 is arranged in abutment withthe peg 23 of the injection arm 21. The second end of the injectionspring 22 is placed on top of the peg 23. The peg 23 is positionedbetween the two ends of the injection spring 22. The peg 23 prevents thesecond end of the injection spring 22 from moving towards the first end.The injection spring 22 exerts a downwards force on the peg 23.

The injection spring 22 can cause a rotation of the injection arm 21, asshown in FIGS. 4A and 4B. When the injection arm 21 is in the retractedposition, as shown in FIG. 4A, the injection spring 22 exerts adownwards force on the peg 23 of the injection arm 21 along the firstaxis. The injection spring 22 can cause the injection arm 21 to rotateto the inserted position, as shown in FIG. 4B.

The trigger arrangement 40 comprises a blocking element 41 and a button42. The blocking element 41 is coupled between the button 42 and theinjection arm 22. The blocking element 41 comprises a thin, generallytriangular element. The blocking element 41 is arranged in a planeperpendicular to the second axis. A first corner of the blocking element41 forms a pivot point of the blocking element 41. The blocking element41 is configured to rotate around the first corner. The blocking element41 is fixed to the housing support 16 at the pivot point. The blockingelement 41 comprises a circular hole positioned at the first corner,configured to fit over a corresponding axle extending from the housingsupport 16. The blocking element 41 freely rotates around the axle ofthe housing support 16. The blocking element 41 is arranged to rotate ina plane perpendicular to the second axis.

A second corner of the blocking element 41 is configured to engage withthe injection arm 21. The blocking element 41 is configured to engagewith the peg 23 of the injection arm 21. The second corner of theblocking element 41 comprise a cut away portion forming a notch. Thepivot point of the blocking element 41 is positioned below the peg 23.The distance between the first corner and the second corner of theblocking element 41 is configured to equal the distance between thepivot point of the blocking element 41 and the peg 23.

The blocking element 41 is configured to rotate between a blockingposition and a release position, as shown in FIGS. 5A, 5B and 5C.

In the blocking position, as shown in FIG. 5A, the blocking element 41is arranged to prevent the injection arm 21 from moving to the insertedposition. The blocking element 41 is rotated such that the second corneris above the pivot point. The blocking element 41 engages with the peg23 to prevent movement of the injection arm 21. The peg 23 is located inthe notch at the second corner of the blocking element 41. The blockingelement 41 prevents the needle 12 from moving to the inserted positionin the blocking position.

In the release position, as shown in FIG. 5B, the blocking element 41 isrotated with respect to the blocking position. The peg 23 is notrestrained by the second corner of the blocking element 41 in therelease position. The blocking element 41 allows the injection arm 21 torotate under the influence of the injection spring 22. The releaseposition of the blocking element 41 allows the injection arm to move tothe inserted position, as shown in FIG. 5C. A side of the blockingelement 41 between the first corner and the second corner may berecessed to allow the movement of the peg 23.

A third corner of the blocking element 41 is configured to be level withthe second corner in the blocking position. The blocking element 41comprises an engaging peg disposed at the third corner. The engaging pegof the blocking element 41 protrudes from the triangular element alongthe second axis. The engaging peg is arranged to engage with the button42.

The button 42 is arranged to be pushed by, for example, a patient orcare-giver. The button 42 extends out of the housing 11. The button 42extends though the upper side 11 a of the housing 11. The button 42 isformed with an enlarged upper end. The button 42 may be formed with anyshape to be pushed by the user. The button 42 may include a leverarrangement.

The button 42 is configured to move freely along the first axis. A lowerportion of the button 42 is in abutment with the engaging peg of theblocking element 41. A downwards force on the button 42 exerts acorresponding downwards force on the blocking element 41. A forceapplied to the upper end of the button 42 therefore causes the blockingelement 41 to rotate. The blocking element 41 is moved from a blockingposition to a release position when the button 42 is pushed.

The trigger arrangement 40 further comprises a button latch comprising,for example, a locking arm 43 and an unlocking lever 44. The locking arm43 is an elongate member. The locking arm 43 is arranged horizontallywithin the housing 11. The locking arm 43 extends along the third axisof the device 10. The locking arm 43 is restrict to move along the thirdaxis only. The locking arm 43 is retained in a horizontal groove formedin the housing support 16. The upper and lower sides of the locking arm43 are in abutment with the sides of the groove formed in the housingsupport 16. The groove restricts the locking arm 43 from movement alongthe first axis.

The locking arm 43 is arranged to engage with the button 42 at one end.The button 42 is formed having a receiving notch on one side. An endportion of the locking arm 43 is configured to fit within the receivingnotch of the button 42. When the locking arm 43 is in position in thenotch of button 42, the upper surface of the locking arm 43 is inabutment with the upper side of the receiving notch. The locking arm 43is restricted from movement along the first axis and can restrict thebutton 42 from movement along the first axis.

The unlocking lever 44 is a V-shaped element. The unlocking lever 44 isarranged to pivot about a midpoint of the unlocking lever 44. A firstend and a second end of the unlocking lever 44 extend away from thepivot point. An acute angle is formed between the two ends of theunlocking lever 44. Alternatively, the unlocking lever 44 may be formedhaving a right angle, or an obtuse angle between the two ends. Furtheralternatively, the two ends of the unlocking lever 44 may be formed tohave different lengths. The unlocking lever 44 is fixed to the housingsupport 16 at the pivot point. The unlocking lever 44 comprises acircular protrusion configured to fit within a corresponding hole formedin the housing support 16. The unlocking lever 44 freely rotates in aplane perpendicular to the second axis.

The unlocking lever 44 is coupled to the locking arm 43 at the firstend. The first end of the unlocking lever 44 comprises a circular pegextending in the direction of the second axis. The circular peg isconfigured to fit within a corresponding hole formed in the locking arm43. The unlocking lever 44 engages with the locking arm 43 at an endfurthest from the button 42. Alternatively, the peg formed at the firstend of the unlocking lever 44 may engage with a notch formed in a lowersurface of the locking arm 43, as shown in FIG. 1 . Furtheralternatively, the first end of the unlocking lever 44 may be engageddirectly with the notch in the locking arm 43.

The point of engagement between the first end of the unlocking lever 44and the locking arm 43 is generally above the pivot point of theunlocking lever 44. Rotation of the unlocking lever 44 results in amovement of the first end of the unlocking lever 44 along the thirdaxis. The unlocking lever 44 engages with the notch formed in thelocking arm 43 when rotated to exert a force on the locking arm 43 alongthe third axis.

A pivoting movement of the unlocking lever 44 causes a sliding movementof the locking arm 43. The locking arm 43 and unlocking lever 44 areconfigured to move between a locked position and an unlocked position.In the locked position, the unlocking lever 44 is engaged with thebutton 42. The unlocking lever 44 prevents the button 42 from beingpushed in the locked position. In the unlocked position, the unlockinglever 44 is disengaged from the button 42. The unlocking lever 44 isarranged to engage with the contact trigger 14 at the second end.

The contact trigger 14 is formed as a rectangular arm. The contacttrigger 14 extends generally along the third axis of the device 10. Thecontact trigger 14 is formed to be relatively thin in the direction ofthe second axis. The contact trigger 14 is configured to pivot about apoint at one end of the rectangular arm. The contact trigger 14 is fixedto the housing support 16 at the pivot point. The contact trigger 14 isformed having a circular peg which is arranged to fit within acorresponding circular hole formed in the housing support 16. Thecontact trigger 14 is configured to freely rotate in the circular holein a plane perpendicular to the second axis.

The contact trigger 14 is movable between a disengaged position and anengaged position, as shown in FIGS. 6A, 6B and 6C. In the engagedposition the contact trigger 14 is disposed entirely within the housing11. The contact trigger 14 extends horizontally from the pivot point,along the third axis. The contact trigger 14 lies parallel to the lowerside 11 b. The lower edge of the contact trigger 14 is above the lowerside 11 b of the housing 11.

In the disengaged position, the contact trigger extends from the lowerside 11 b of the housing 11. The contact trigger 14 is rotated withrespect to the engaged position. The contact trigger 14 is angled downfrom pivot point. The contact trigger 14 extends through a correspondingslot formed in the lower side 11 b. The contact trigger 14 is biasedtowards the disengaged position. The end of the contact trigger 14 whichis furthest from the pivot point forms the lowest point of the contacttrigger 14 in the disengaged position. The lowest corner of the contacttrigger 14 in the disengaged position may be truncated. The lowestcorner may be formed as an edge which is parallel to the lower side 11 bin the disengaged position.

An upper side of the contact trigger 14 is in contact with the unlockinglever 44. FIG. 6A shows the contact trigger in an initial state, in thedisengaged position. The second end of the unlocking lever 44 comprisesa protruding part. The protruding part extends from the unlocking lever44 along the second axis. The protruding part of the locking arm restson an upper side of the contact trigger 14. Alternatively, theprotruding part passes through a corresponding hole formed in thecontact trigger 14, as shown in FIG. 2 . Further alternatively, thecontact trigger 14 may engage directly with a lower surface of thesecond end of the unlocking lever 44.

A force applied upwards along the first axis to the contact trigger 14exerts a corresponding upwards force on the unlocking lever 44. Thesecond end of the unlocking lever 44, which is engaged with the contacttrigger 14, is positioned to the side of the pivot point of theunlocking lever 44. As the second end of the unlocking lever 44 movesupwards along the first axis, the unlocking lever 44 rotates around thepivot point. The rotation moves the first end of the unlocking lever 44along the third axis, causing a sliding movement of the locking arm 43as described above.

FIG. 6B shows the contact trigger 14 in the engaged position. Movementof the contact trigger 14 from the disengaged position to the engagedposition causes rotation of the unlocking lever 44 and moves the lockingarm horizontally, as described. The button 42 can be moved along thefirst axis when the contact trigger 14 is in the engaged position. Thebutton 42 can be pressed to rotate the blocking element 41 as describedabove, as shown in FIG. 6C.

The needle retraction mechanism 30 comprises a return actuator 31 and areturn spring 32.

The return actuator 31 comprises an engaging part 33 for engaging withthe blocking element 41, a peg 34 for engaging with the return spring 32and a locking part 35 for engaging with the contact trigger 14. Theelements of the return actuator 31 are formed in a single piece. Thereturn actuator 31 is arranged to rotate in a plane perpendicular to thesecond axis. The return actuator 31 is fixed to the housing support 16at a pivot point. The return actuator 31 is formed having a circularhole which fits over a corresponding axle extending from the housingsupport 16. The return actuator 31 is configured to rotate freely aroundthe axle of the housing support 16. The return actuator 31 is arrangedon the same axle as the injection arm 21 and the injection spring 22.According to the embodiment, the return actuator 31 is mounted betweenthe injection arm 21 and the housing support 16.

The engaging part 33 protrudes along second axis from the returnactuator 31. The engaging part 33 extends the in direction of theinjection arm 21. The engaging part 33 is positioned below the injectionarm 31. The engaging part 33 comprises a flat surface for engaging withthe lower side of the injection arm 21.

The peg 34 extends along second axis from the return actuator 31. Thepeg 34 extends from the opposite side of the return actuator 31 to theengaging part 33. The return actuator 31 is arranged between to theinjection arm 21 and the return spring 32. The peg 34 is arranged toengage with the return spring 32.

The return spring 32 is an example of a retraction driver to drive theretraction mechanism 30. The return spring 32 is a torsion spring, forexample, a wire coil spring with a straight portion extending from eachend of the coil. The ends of the return spring 32 extend with an anglebetween them. The return spring 32 is tensioned so as to increase theangle between the ends of the coil when released. Alternatively, theretraction driver may be, for example, a linear coil spring, a hydraulicor pneumatic piston, or an electric motor. A single electric motor maybe used to drive the insertion mechanism 20 and the retraction mechanism30.

The coil of the return spring 32 is fixed in position with respect tothe housing support 16. The coil is arranged around a peg which extendsfrom the housing support 16 along the second axis. A first end of thereturn spring 32 is fixed in position. The first end is fixedly attachedto the contact trigger 14, as will be described below. Alternatively,the first end of the return spring 32 may be fixed to an element of thehousing 11 or support 16. The first end of the return spring 32 isprevented from moving away from a second end of the return spring 32.The second end of the return spring 32 is coupled to the peg 34 of thereturn actuator 31. The second end of the return spring 32 is formed ina loop which wraps around the peg 34. The return spring 32 exerts aforce pushing against the peg 34.

The return spring 32 is configured to move the needle 12 from theinserted position to the retracted position, as shown in FIGS. 7A and7B. The return actuator 31 is configured to move between a firstposition and a second position, in response to a force from the returnspring 32. In the first position, as shown in FIG. 7A, the returnactuator 31 is positioned below the pivot point. The engaging part 33 isin the lowest position along the first axis. When the injection arm 21is in the inserted position, the lower side of the injection arm 21 isin abutment with the engaging part 33.

The return spring 32 is arranged to apply a force which moves the returnactuator 31 to the second position. The first end of the return spring32 is positioned to the side of the return actuator 32, along the thirdaxis. The tension of the return spring 32 pushes the two ends apart. Thereturn spring 32 exerts a force on the peg 34 along the third axis. Thereturn actuator 32 rotates to the second position in response to theforce from the return spring 32. The return spring 32 pushes the returnactuator 32 against the injection arm 21.

The second position of the return actuator 31 is shown in FIG. 7B.Rotation of the return actuator 32 moves the engaging part 33 along thethird axis and upwards along the first axis. The engaging part 33 exertsa corresponding force on the injection arm 21 upwards along the firstaxis. The injection arm 21 rotates in response to the force from theengaging part 33. The injection arm 21 is rotated from the insertedposition to the retracted position by the movement of the returnactuator 31.

The force exerted by the return spring 32 is larger than the forceexerted by the injection spring 22. The injection arm 21 and the needle12 will rest in the retracted position when both springs act on theinjection arm 21. Alternatively, the injection arm 21 may be disengagedfrom the injection spring 22 when moved from the retracted position tothe inserted position.

The engaging part 33 of the return actuator 31 is further configured toengage with the blocking element 41. The engaging part 33 extendsdownwards from the surface which engages the injection arm 21. When thereturn actuator 31 is in the first position, the engaging part 33extends along the first axis. The engaging part 33 provides a verticallyextending surface to engage with the blocking element 41. The engagingpart 33 is arranged to engage a blocking part 41 a of the blockingelement 41.

The blocking part 41 a comprises a rectangular protrusion extendingalong the second axis from the blocking element 41. The blocking part 41a is positioned part way between the first corner and the third cornerof the blocking element 41. The interaction between the engaging part 33and the blocking part 41 a can be seen in FIGS. 5A and 5B.

When the blocking element 41 is in the blocking position, and the returnactuator 31 is in the first position, the engaging part 33 is engagedwith the blocking part 41 a. FIG. 5A shows the blocking part 41 a inabutment with the engaging part 33. The engaging part 33 and theblocking part 41 a are in contact along a vertical surface. The blockingpart 41 a cannot move along the third axis due to the fixed pivot pointof the blocking element 41. The engaging part 33 is restrained frommoving along the third axis in the direction of the blocking part 33.The blocking part 33a is arranged on the side of the engaging part 33away from the return spring 32. The engaging part 33 is pushed againstthe blocking part 41 a by the return spring 32. The return actuator 31is prevented from moving to the second position by the blocking part 41a.

When the blocking element 41 is rotated to the release position, asshown in FIG. 5B, the blocking part 41 a moves down along the firstaxis. The blocking part 41 a is moved below the extent of the engagingpart 33. The blocking part 41 a is not in contact with the engaging part33 in the release position. The engaging part 33 can move past theblocking part 41 a and the return actuator 31 can move to the secondposition.

The locking part 35 of the return actuator 31 is configured to engagewith the contact trigger 14. The locking part 35 is a rectangularprotrusion which extends from the return actuator 31 along the secondaxis. The locking part 35 extends from the other side of the returnactuator 31 to the engaging part 33 and the peg 34. The locking part 35is elongate along the first axis. The locking part 35 provides avertically extending surface to engaging with the contact trigger 14.The locking part 35 is configured to engage with a corresponding notchedportion of the contact trigger 14.

An interaction between the locking part 35 and the contact trigger 14 isshown in FIGS. 8A, 8B and 8C.

An upper surface of the contact trigger 14 is formed to have arectangular slot 15. The shape of the contact trigger corresponds to theshape of the locking part 35. An upper section of the slot 15 may beenlarged to include an additional circular portion. FIG. 8A shows thelocking part 35 engaged with the contact trigger 14. The return actuator31 is in the first position and the contact trigger 14 is in the engagedposition. The locking part 35 is in abutment with the vertical sides ofthe slot 15. The locking part 35 is restrained from moving along thethird axis by the side wall of the slot 15. The return spring 32 pushesthe locking part 35 against the side of the slot 15. The return actuator31 is restrained from moving to the second position.

FIG. 8B shows the contact trigger 14 in the disengaged position. Thecontact trigger 14 is moved down with respect to the locking part 35.The locking part 35 is not in contact with the side walls of the slot15. The contact trigger 14 is moved such that the locking part 35 isaligned with the circular portion formed in the contact trigger 14. Thelocking part 35 can move along the third axis. The return actuator 31can be rotated to the second position, as shown in FIG. 8C.

The return spring 32 is configured to bias the contact trigger 14 to thedisengaged position. The first end return spring 32 is fixedly attachedto the contact trigger 14. The first end of the return spring 32 forms aloop around a corresponding protrusion on the surface of the contacttrigger 14. The return spring 32 is attached to the contact trigger 14at a point below the pivot point of the contact trigger 14. The returnspring 32 exerts a force on the contact trigger 14 along the third axis.The return spring 32 rotates the contact trigger 14 from the engagedposition to the disengaged position. The contact trigger 14 can be movedto the engaged position on contact with the skin of a patient.

Operation of the contact trigger 14 and the medicament deliverymechanism will be described in detail with respect to FIGS. 8 to 12 .

FIG. 1 shows the device 10 in an initial state. The contact trigger 14is in the disengaged position. The locking arm 43 is in the lockedposition. The button 42 is locked. The blocking element 41 is in theblocking position. The injection arm 21 and the needle 12 are in theretracted position. The return actuator 31 is in the first position.

FIG. 8 shows the device 10 in an engaged state. The device 10 is shownin position on the skin of a patient. The device 10 may be placed inposition by a patient themselves or by a care-giver. Contact with theskin of a patient causes the contact trigger 14 to move from thedisengaged position to the engaged position.

The contact trigger 14 is engaged with the second end of the unlockinglever 44. Movement of the contact trigger 14 to the engaged positioncauses the unlocking lever 44 and locking arm 42 to move from the lockedposition to the unlocked position. The trigger mechanism 40 of thedevice 10 can be unlocked by movement of the contact trigger 14 to theengaged position. The trigger mechanism 40 can be unlocked by placingthe lower side 11 b of the device 10 in position on the skin of apatient. In the engaged state, the button 42 can be pushed by a patientor care-giver to activate the insertion mechanism 20.

The insertion mechanism 20 of the device 10 cannot be activated when thedevice 10 is not engaged with the skin of a patient. The device 10avoids activation of the insertion mechanism 20 and deployment of theneedle before the device 10 is properly attached to a patient.Additionally, when the contact trigger 14 is moved to the engagedposition the trigger mechanism 40 can be automatically unlocked. Thedevice 10 can provide an operation which is safer and more convenientfor the patient or care-giver operating the device.

The engaging part 33 of the return actuator 31 is configured to engagewith the slot 15 when the contact trigger is in the engaged position.The slot 15 is configured to prevent the return actuator 31 from movingto the second position. As shown in FIG. 8 , the return actuator 31 isprevented from moving to the second position by the blocking element 41and by the contact trigger 14.

FIG. 9 shows the device 10 in a first activated state. The button 42 ispushed down. The button 42 engages with the blocking element 41 whenpushed to move the blocking element 41 from the blocking position to therelease position. The blocking element 41 is disengaged from the peg 23of the injection arm 21. The injection arm 21 is free to move to theinserted position. The blocking element 41 is further disengaged fromthe return actuator 31. The return actuator 31 is retained in the firstposition by the contact trigger 14.

FIG. 10 shows the device 10 in a second activated state. The needle 12is moved to the inserted position. The injection arm 21 is moved to theinserted position by the injection spring 22. The injection arm 21pivots until the peg 23 engages with the blocking element 41. Theblocking element 41 is configured to limit the movement of the injectionarm 21 in the inserted position. The injection arm 21 moves the needle12 through the aperture 13 and causes the needle 12 to be injected intothe skin of a patient. Once the needle insertion mechanism 20 has beenactivated, the medicament delivery process can begin to deliverymedicament through the needle 12. The medicament delivery process may beactivated manually by a patient or care-giver. Alternatively, themedicament delivery process may be activated automatically following theactivation of the needle insertion mechanism 20.

The engaging part 33 of the return actuator 31 is disposed in the slot15 of the contact trigger 14. The return actuator 31 is retained in thefirst position. When the insertion mechanism 20 has been activated, theretraction mechanism 30 can be activated according to the position ofthe contact trigger 14. The contact trigger 14 is configured to activatethe retraction mechanism 30 when the device 10 is removed from the bodyof a patient.

FIG. 11 shows the device 10 is a first completed state. The medicamentdelivery process is completed and the device 10 is detached from theskin of the patient. The contact trigger 14 is moved from the engagedposition to the disengaged position by the return spring 32. The contacttrigger 14 extends from the lower side 11 b of the housing 11 in thedisengaged position. As the device 20 is lifted away from the skin of apatient, the contact trigger 14 is maintained in contact with the skinby the return spring 32 until the disengaged position is reached. Thecontact trigger 14 can cover the needle 12 as the device 10 is detachedfrom a patient. The contact trigger 14 can protect the needle 12 untilthe retraction mechanism 30 is activated.

In the completed state of the device 10, the engaging part 33 isdisengaged from the slot 15. The return actuator 31 is free to move tothe second position. The return spring 32 is configured to move thereturn actuator 31 to the second position. The retraction mechanism 30can be automatically activated by the contact trigger 14 when the device10 is detached from the skin of a patient.

FIG. 12 shows the device 10 in a second completed state. The returnactuator 31 has been moved to the second position by the return spring32. The return actuator 31 engages with the injection arm 21 and movesthe injection arm 21 to the retracted position. The needle 12 is movedto the retracted position by the retraction mechanism 30. The engagingpart 33 of the return actuator 31 is arranged to engage with the contacttrigger 14 when the return actuator is in the second position. Theengaging part 33 is configured to prevent the contact trigger 14 frommoving to the engaged position. The contact trigger 14 is maintained inthe disengaged position by the engaging part 33 when the device 10 hasbeen used. The device 10 provides a clear indication that the medicamentdelivery process is completed, and avoids an attempt to use the device10 a second time.

The retraction mechanism 30 of the device 10 can be activatedautomatically when the contact trigger 14 moves to the disengagedposition. The needle 12 can be automatically moved to the retractedposition when the medicament delivery process is completed. The device10 can avoid injury caused by exposure of the needle 12 when the device10 is detached from a patient. The device 10 can provide an operationwhich is safer and more convenient for the patient or care-giveroperating the device.

Although a few embodiments have been shown and described, it will beappreciated by those skilled in the art that changes may be made inthese embodiments without departing from the invention, the scope ofwhich is defined in the appended claims. Various components of differentembodiments may be combined where the principles underlying theembodiments are compatible.

For example, the user activated button may be any form of user actuatedinput, for instance a switch or lever. The button may be an electronictouch sensor or a soft button provided on a touchscreen. The button maybe a component of the needle insertion mechanism. The button may bearranged to push the needle directly from the retracted position to theinserted position. The blocking element may be slidably mounted andconfigured to slide from the blocking position to the release positionin response to, for example, a pushing force from the button or arotating action of a user actuated lever.

The locking arm may be arranged to engage with the blocking element toprevent movement of the blocking element from the blocking position tothe release position. Alternatively, the locking arm may engage with theinjection arm or the needle support directly, such that the button canbe pushed with no effect until the needle insertion mechanism isunlocked. The button may include a biasing means to reset the positionwhen pushed and released. Further alternatively, the locking arm mayreplace the blocking element such that the injection arm is releasedwhen the locking arm is disengaged. In this way, the needle insertionmechanism may be activated by the contact trigger.

The contact trigger may be a linear arrangement configured to moveperpendicularly out of the lower side of the housing. A coil spring maybe arranged to urge the contact trigger along a linear axis.Alternatively, the contact trigger may be a button or lever mounted onthe lower side of the case, or may be provided by a proximity or contactsensor.

The needle insertion mechanism may be provided by a coil spring oranother linear actuator, rather than the pivoting arrangement describedabove. A spring or linear needle driver may be mounted on the axis ofthe needle to drive the needle directly into the inserted position. Theinjection spring and return spring may be formed by any suitable biasingmeans, for example, a compression coil spring, a tension coil spring, aflat spring or by an elastic (e.g. rubber or polymer) element.Alternatively, the needle insertion mechanism and needle retractionmechanism may be driven by any suitable linear or rotary actuator suchas a motor, an electromagnetic driver or a pneumatic or hydraulicdriver.

A plurality of needles may be provided in an array for injection by theneedle insertion mechanism, or a plurality of needle insertionmechanisms may be provided.

The terms “drug” or “medicament” are used synonymously herein anddescribe a pharmaceutical formulation containing one or more activepharmaceutical ingredients or pharmaceutically acceptable salts orsolvates thereof, and optionally a pharmaceutically acceptable carrier.An active pharmaceutical ingredient (“API”), in the broadest terms, is achemical structure that has a biological effect on humans or animals. Inpharmacology, a drug or medicament is used in the treatment, cure,prevention, or diagnosis of disease or used to otherwise enhancephysical or mental well-being. A drug or medicament may be used for alimited duration, or on a regular basis for chronic disorders.

As described below, a drug or medicament can include at least one API,or combinations thereof, in various types of formulations, for thetreatment of one or more diseases. Examples of API may include smallmolecules having a molecular weight of 500 Da or less; polypeptides,peptides and proteins (e.g., hormones, growth factors, antibodies,antibody fragments, and enzymes); carbohydrates and polysaccharides; andnucleic acids, double or single stranded DNA (including naked and cDNA),RNA, antisense nucleic acids such as antisense DNA and RNA, smallinterfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleicacids may be incorporated into molecular delivery systems such asvectors, plasmids, or liposomes. Mixtures of one or more drugs are alsocontemplated.

The term “drug delivery device” shall encompass any type of device orsystem configured to dispense a drug or medicament into a human oranimal body. Without limitation, a drug delivery device may be aninjection device (e.g., syringe, pen injector, auto injector,large-volume device, pump, perfusion system, or other device configuredfor intraocular, subcutaneous, intramuscular, or intravasculardelivery), skin patch (e.g., osmotic, chemical, micro-needle), inhaler(e.g., nasal or pulmonary), an implantable device (e.g., drug- orAPI-coated stent, capsule), or a feeding system for thegastro-intestinal tract. The presently described drugs may beparticularly useful with injection devices that include a needle, e.g.,a hypodermic needle for example having a Gauge number of 24 or higher.

The drug or medicament may be contained in a primary package or “drugcontainer” adapted for use with a drug delivery device. The drugcontainer may be, e.g., a cartridge, syringe, reservoir, or other solidor flexible vessel configured to provide a suitable chamber for storage(e.g., short- or long-term storage) of one or more drugs. For example,in some instances, the chamber may be designed to store a drug for atleast one day (e.g., 1 to at least 30 days). In some instances, thechamber may be designed to store a drug for about 1 month to about 2years. Storage may occur at room temperature (e.g., about 20° C.), orrefrigerated temperatures (e.g., from about −4° C. to about 4° C.). Insome instances, the drug container may be or may include a dual-chambercartridge configured to store two or more components of thepharmaceutical formulation to-be-administered (e.g., an API and adiluent, or two different drugs) separately, one in each chamber. Insuch instances, the two chambers of the dual-chamber cartridge may beconfigured to allow mixing between the two or more components prior toand/or during dispensing into the human or animal body. For example, thetwo chambers may be configured such that they are in fluid communicationwith each other (e.g., by way of a conduit between the two chambers) andallow mixing of the two components when desired by a user prior todispensing. Alternatively, or in addition, the two chambers may beconfigured to allow mixing as the components are being dispensed intothe human or animal body.

The drugs or medicaments contained in the drug delivery devices asdescribed herein can be used for the treatment and/or prophylaxis ofmany different types of medical disorders. Examples of disordersinclude, e.g., diabetes mellitus or complications associated withdiabetes mellitus such as diabetic retinopathy, thromboembolismdisorders such as deep vein or pulmonary thromboembolism. Furtherexamples of disorders are acute coronary syndrome (ACS), angina,myocardial infarction, cancer, macular degeneration, inflammation, hayfever, atherosclerosis and/or rheumatoid arthritis. Examples of APIs anddrugs are those as described in handbooks such as Rote Liste 2014, forexample, without limitation, main groups 12 (anti-diabetic drugs) or 86(oncology drugs), and Merck Index, 15th edition.

Examples of APIs for the treatment and/or prophylaxis of type 1 or type2 diabetes mellitus or complications associated with type 1 or type 2diabetes mellitus include an insulin, e.g., human insulin, or a humaninsulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1analogues or GLP-1 receptor agonists, or an analogue or derivativethereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or apharmaceutically acceptable salt or solvate thereof, or any mixturethereof. As used herein, the terms “analogue” and “derivative” refer toany substance which is sufficiently structurally similar to the originalsubstance so as to have substantially similar functionality or activity(e.g., therapeutic effectiveness). In particular, the term “analogue”refers to a polypeptide which has a molecular structure which formallycan be derived from the structure of a naturally occurring peptide, forexample that of human insulin, by deleting and/or exchanging at leastone amino acid residue occurring in the naturally occurring peptideand/or by adding at least one amino acid residue. The added and/orexchanged amino acid residue can either be codeable amino acid residuesor other naturally occurring residues or purely synthetic amino acidresidues. Insulin analogues are also referred to as “insulin receptorligands”. In particular, the term “derivative” refers to a polypeptidewhich has a molecular structure which formally can be derived from thestructure of a naturally occurring peptide, for example that of humaninsulin, in which one or more organic substituent (e.g. a fatty acid) isbound to one or more of the amino acids. Optionally, one or more aminoacids occurring in the naturally occurring peptide may have been deletedand/or replaced by other amino acids, including non-codeable aminoacids, or amino acids, including non-codeable, have been added to thenaturally occurring peptide.

Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) humaninsulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulinglulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28)human insulin (insulin aspart); human insulin, wherein proline inposition B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein inposition B29 Lys may be replaced by Pro; Ala(B26) human insulin;Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) humaninsulin.

Examples of insulin derivatives are, for example,B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®);B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin;B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 humaninsulin; B28-N-palmitoyl-LysB28ProB29 human insulin;B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30human insulin; B29-N—(N-palmitoyl-gamma-glutamyl)-des(B30) humaninsulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30)human insulin (insulin degludec, Tresiba®);B29-N—(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin;B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin andB29-N-(ω-carboxyhepta¬decanoyl) human insulin.

Examples of GLP-1, GLP-1 analogues and GLP-1 receptor agonists are, forexample, Lixisenatide (Lyxumia®, Exenatide (Exendin-4, Byetta®,Bydureon®, a 39 amino acid peptide which is produced by the salivaryglands of the Gila monster), Liraglutide (Victoza®), Semaglutide,Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®),rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide/HM-11260C, CM-3,GLP-1 Eligen, ORMD-0901, NN-9924, NN-9926, NN-9927, Nodexen,Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701,MAR709, ZP-2929, ZP-3022, TT-401, BHM-034. MOD-6030, CAM-2036, DA-15864,ARI-2651, ARI-2255, Exenatide-XTEN and Glucagon-Xten.

An example of an oligonucleotide is, for example: mipomersen sodium(Kynamro®), a cholesterol-reducing antisense therapeutic for thetreatment of familial hypercholesterolemia.

Examples of DPP4 inhibitors are Vildagliptin, Sitagliptin, Denagliptin,Saxagliptin, Berberine.

Examples of hormones include hypophysis hormones or hypothalamushormones or regulatory active peptides and their antagonists, such asGonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin),Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin,Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

Examples of polysaccharides include a glucosaminoglycane, a hyaluronicacid, a heparin, a low molecular weight heparin or an ultra-lowmolecular weight heparin or a derivative thereof, or a sulphatedpolysaccharide, e.g. a poly-sulphated form of the above-mentionedpolysaccharides, and/or a pharmaceutically acceptable salt thereof. Anexample of a pharmaceutically acceptable salt of a poly-sulphated lowmolecular weight heparin is enoxaparin sodium. An example of ahyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodiumhyaluronate.

The term “antibody”, as used herein, refers to an immunoglobulinmolecule or an antigen-binding portion thereof. Examples ofantigen-binding portions of immunoglobulin molecules include F(ab) andF(ab′)2 fragments, which retain the ability to bind antigens. Theantibody can be polyclonal, monoclonal, recombinant, chimeric,de-immunized or humanized, fully human, non-human, (e.g., murine), orsingle chain antibody. In some embodiments, the antibody has effectorfunction and can fix a complement. In some embodiments, the antibody hasreduced or no ability to bind an Fc receptor. For example, the antibodycan be an isotype or subtype, an antibody fragment or mutant, which doesnot support binding to an Fc receptor, e.g., it has a mutagenized ordeleted Fc receptor binding region. The term antibody also includes anantigen-binding molecule based on tetravalent bispecific tandemimmunoglobulins (TBTI) and/or a dual variable region antibody-likebinding protein having cross-over binding region orientation (CODV).

The terms “fragment” or “antibody fragment” refer to a polypeptidederived from an antibody polypeptide molecule (e.g., an antibody heavyand/or light chain polypeptide) that does not comprise a full-lengthantibody polypeptide, but that still comprises at least a portion of afull-length antibody polypeptide that is capable of binding to anantigen. Antibody fragments can comprise a cleaved portion of a fulllength antibody polypeptide, although the term is not limited to suchcleaved fragments. Antibody fragments that are useful include, forexample, Fab fragments, F(ab′)2 fragments, scFv (single-chain Fv)fragments, linear antibodies, monospecific or multispecific antibodyfragments such as bispecific, trispecific, tetraspecific andmultispecific antibodies (e.g., diabodies, triabodies, tetrabodies),monovalent or multivalent antibody fragments such as bivalent,trivalent, tetravalent and multivalent antibodies, minibodies, chelatingrecombinant antibodies, tribodies or bibodies, intrabodies, nobodies,small modular immunopharmaceuticals (SMIP), binding-domainimmunoglobulin fusion proteins, camelized antibodies, and VHH containingantibodies. Additional examples of antigen-binding antibody fragmentsare known in the art.

The terms “Complementarity-determining region” or “CDR” refer to shortpolypeptide sequences within the variable region of both heavy and lightchain polypeptides that are primarily responsible for mediating specificantigen recognition. The term “framework region” refers to amino acidsequences within the variable region of both heavy and light chainpolypeptides that are not CDR sequences, and are primarily responsiblefor maintaining correct positioning of the CDR sequences to permitantigen binding. Although the framework regions themselves typically donot directly participate in antigen binding, as is known in the art,certain residues within the framework regions of certain antibodies candirectly participate in antigen binding or can affect the ability of oneor more amino acids in CDRs to interact with antigen.

Examples of antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).

Pharmaceutically acceptable salts of any API described herein are alsocontemplated for use in a drug or medicament in a drug delivery device.Pharmaceutically acceptable salts are for example acid addition saltsand basic salts.

Those of skill in the art will understand that modifications (additionsand/or removals) of various components of the APIs, formulations,apparatuses, methods, systems and embodiments described herein may bemade without departing from the full scope and spirit of the presentinvention, which encompass such modifications and any and allequivalents thereof.

1-17. (canceled)
 18. A medicament delivery device comprising: a needleconfigured to move between a retracted position and an insertedposition; an insertion mechanism configured to move the needle from theretracted position to the inserted position when activated; a lockingarm which, in a locked position, is engaged with the insertion mechanismto prevent activation of the insertion mechanism and, in an unlockedposition, is disengaged from the insertion mechanism; a retractionmechanism configured to move the needle from the inserted position tothe retracted position when activated; and a trigger configured to movebetween a disengaged position and an engaged position, wherein thetrigger is arranged to be moved from the disengaged position to theengaged position when the medicament delivery device is placed on a bodyof a patient, and on moving from the disengaged position to the engagedposition, the trigger is configured to move the locking arm from thelocked position to the unlocked position, and wherein, on moving fromthe engaged position to the disengaged position, the trigger isconfigured to activate the retraction mechanism.
 19. The medicamentdelivery device of claim 18, wherein the locking arm is slidably mountedand is pivotably coupled to an unlocking lever such that a rotation ofthe unlocking lever causes a sliding movement of the locking arm. 20.The medicament delivery device of claim 19, wherein the unlocking leveris pivotably mounted at a midpoint, and comprises a first end pivotablycoupled to the locking arm and a second end arranged to engage with thetrigger.
 21. The medicament delivery device of claim 20, wherein theunlocking lever is formed having an angle at the midpoint, and isarranged such that movement of the trigger along a first directioncauses a rotation of the first end, and a resulting rotation of thesecond end causes a sliding movement of the locking arm along a seconddirection different to the first direction.
 22. The medicament deliverydevice of claim 18, wherein the trigger, on moving from the disengagedposition to the engaged position, is configured to engage with anunlocking lever to rotate the unlocking lever, such that the locking armis moved from the locked position to the unlocked position.
 23. Themedicament delivery device of claim 18, wherein: the insertion mechanismcomprises a user actuator arranged to be pushed by a user to activatethe insertion mechanism; and in the locking position, an end of thelocking arm is disposed within a receiving notch formed in the useractuator to prevent movement of the user actuator in a directionperpendicular to the locking arm and, in the unlocked position, thelocking arm is withdrawn from the receiving notch.
 24. The medicamentdelivery device of claim 23, wherein the insertion mechanism comprises:a biasing element configured to urge the needle towards the insertedposition; and a blocking element arranged, in a blocking position, toprevent the needle from moving from the retracted position to theinserted position and arranged, in a release position, to allow theneedle to move from the retracted position to the inserted position,wherein the user actuator is arranged to urge the blocking element fromthe blocking position to the release position when pushed.
 25. Themedicament delivery device of claim 24, wherein the insertion mechanismcomprises: an injection arm pivotably mounted at one end and pivotablycoupled to the needle at the other end; and a guide member configured torestrict movement of the needle to a linear movement between theretracted position and the inserted position in response to a pivotingaction of the injection arm, wherein the blocking element in theblocking position is arranged in abutment with the injection arm toprevent movement of the needle to the inserted position.
 26. Themedicament delivery device of claim 25, wherein: the blocking element isformed having a substantially triangular shape which is pivotablymounted at a first corner to rotate between the blocking position andthe release position; and a second corner of the blocking element is inabutment with the injection arm when the blocking element is in theblocking position, and the user actuator is configured to apply a forceat a third corner of the blocking element when pushed.
 27. Themedicament delivery device of claim 25, wherein: the biasing element ofthe insertion mechanism comprises a coil spring fixed around a pivot ofthe injection arm; and a first end of the coil spring is fixed inposition, and a second end of the coil spring extends along theinjection arm to push the injection arm towards the inserted position.28. The medicament delivery device of claim 25, wherein the retractionmechanism comprises a return actuator pivotably mounted to rotate aroundthe pivot of the injection arm between a first position and a secondposition, and the return actuator in the first position is arranged toabut with the injection arm in the inserted position, and the returnactuator is configured to urge the injection arm and the needle to theretracted position of the needle when moved to the second position. 29.The medicament delivery device of claim 28, wherein the blockingelement, in the blocking position, is engaged with the return actuatorto retain the return actuator in the first position and, in the releaseposition, is disengaged from the return actuator.
 30. The medicamentdelivery device of claim 28, wherein the retraction mechanism comprisesa biasing element configured to urge the return actuator towards thesecond position, wherein the trigger in the engaged position isconfigured to engage with the return actuator to retain the returnactuator in the first position, and the trigger in the disengagedposition is disengaged from the return actuator.
 31. The medicamentdelivery device of claim 30, wherein the biasing element of theretraction mechanism comprises a coil spring, having a first end of thecoil spring fixed in position and a second end of the coil spring inabutment with the return actuator to push the return actuator towardsthe second position, and wherein the coil spring is not fixed inposition between the first end and second end.
 32. The medicamentdelivery device of claim 31, wherein the trigger is pivotably mounted torotate between the engaged position and the disengaged position, andwherein the first end of the coil spring of the retraction mechanism isfixed to the trigger to bias the trigger towards the disengagedposition.
 33. The medicament delivery device of claim 29, wherein: thetrigger is formed having a retaining slot; and in the first position,the return actuator is aligned with the retaining slot, disposed withinthe retaining slot, and prevented from moving to the second positionwhen the trigger is in the engaged position, and is released by theretaining slot when the trigger moves from the engaged position to thedisengaged position; and in the second position, the return actuator isnot aligned with the retaining slot and abuts with the trigger toprevent the trigger from moving from the disengaged position to theengaged position.
 34. The medicament delivery device of claim 18,comprising an outer housing, wherein the needle is disposed within theouter housing in the retracted position and extends out of the outerhousing through a contact surface of the outer housing in the insertedposition, wherein the trigger extends out of the outer housing throughthe contact surface of the outer housing in the disengaged position,wherein the trigger in the disengaged position extends beyond the needlein the inserted position, and wherein the trigger is configured to bemoved from the disengaged position to the engaged position when thecontact surface is placed against a user.
 35. The medicament deliverydevice of claim 34, wherein a length of the outer housing, measuredperpendicular to the contact surface, is smaller than a width of theouter housing.
 36. A medicament delivery device comprising: a housing; aneedle configured to move relative to the housing between a retractedposition and an inserted position; a locking arm configured to moverelative to the housing from a first position in which movement of theneedle from the retracted position to the inserted position is preventedto a second position in which movement of the needle from the retractedposition to the inserted position is allowed; and a trigger elementconfigured to move relative to the housing from an extended position toa retracted position, the medicament delivery device configured suchthat (i) movement of the trigger element from the extended position tothe retracted position causes the locking arm to move from the firstposition to the second position and (ii) movement of the trigger elementfrom the retracted position to the extended position causes the needleto move from the inserted position to the retracted position.
 37. Amethod comprising: moving a trigger of a medicament delivery devicerelative to a housing of the medicament delivery device from a firstposition in which a locking arm is engaged with an insertion mechanismof the medicament delivery device to prevent movement of a needlerelative to the housing to a second position in which the locking arm isdisengaged from the insertion mechanism, wherein when the trigger is inthe second position, the insertion mechanism moves the needle relativeto the housing from a retracted position to an inserted position, andafter moving the needle relative to the housing from the retractedposition to the inserted position, the trigger moves relative to thehousing from the second position to the first position causing theneedle to be moved by a retraction mechanism of the medicament deliverydevice from the inserted position to the retracted position.